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Summary

for people ages 12–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. The subject questionnaires will be completed over a series of timepoints and the subject's information from the subjects' electronic medical record will be abstracted for research data at various timepoints as well. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy.

Details

Participants will complete the MOON Shoulder Instability patient form to document shoulder function and overall health status. The questionnaire will take 20-30 minutes to complete. The patient questionnaire will be completed once in the clinic before surgery and then will be mailed to them at 2 years, 6 years, 10 years and 20 years after surgery. An additional pre-surgical questionnaire will be completed on-line and will become part of the participant's UIHC electronic medical record. This is the standard of care for all shoulder instability patients in the Sports Medicine Clinic, regardless of study participation. Reviewing the noted pre-surgical questionnaire will be a review of data collected as part of clinical activity and is not considered a research-initiated data collection. Study-specific information, such as follow-up contact information, will be collected at this time. The follow-up questionnaires will be mailed to participants with a postage-paid return envelope by the coordinating center at University of Iowa. The coordinating center will also call participants prior to mailing follow-up questionnaires to confirm that the mailing information is correct and to ascertain whether the participant has had any subsequent shoulder surgery. At the two, six, ten, and twenty year time-points the participant's local medical record will be queried to identify any subsequent shoulder surgery occurring at the University of Iowa Hospital and Clinics. Physicians will complete an initial evaluation form detailing range of motion and radiologic imaging information when the patient is indicated for surgery. They will complete an in depth evaluation form detailing specific pathologies of the shoulder and any operative findings at the time of surgery. Finally at the 4-6 month time point following surgery the physician will complete a clinical follow up form on range of motion and shoulder function.

Additionally, for recruitment purposes, we will need to obtain potential subjects' demographic data, as well as any information related to the diagnosis and treatment of their shoulder instability, from their medical record. This information will be obtained from potential subjects' medical records prior to consent has been given. We will review subjects' medical record at each of the follow-up timepoints (4-6 months, and 2, 6, 10, and 20 years) for updated demographic information, as well as information related specifically to their diagnosis of shoulder instability. This may include information about the initial surgery, as well as subsequent shoulder surgeries, complications, additional treatment and physical therapy notes, x-rays or other images, and outcome measures for pain and functionality.

Keywords

Other Instability, Shoulder Dislocations Subluxations Recurrent Dislocation of Shoulder Region instability

Eligibility

You can join if…

Open to people ages 12–99

This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.

Inclusion criteria:

  • Anterior, posterior, and inferior instability
  • Ages 12-99
  • Open and arthroscopic repair
  • Revision of a previous shoulder instability repair
  • Latarjet/bone augmentation

You CAN'T join if...

  • Workers compensation patients
  • Prisoners
  • Non-English speaker
  • Not mentally competent
  • Unable/unwilling to return for clinical follow-up
  • Arthroplasty patients
  • Rotator cuff tears
  • Fractures

Locations

  • University of Colorado accepting new patients
    Boulder, Colorado, 80304, United States
  • Orthopedic Institute accepting new patients
    Sioux Falls, South Dakota, 57105, United States
  • University of Iowa accepting new patients
    Iowa City, Iowa, 52242, United States
  • Washington University accepting new patients
    St. Louis, Missouri, 63110, United States
  • Vanderbilt University accepting new patients
    Nashville, Tennessee, 37232-8774, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48109-0328, United States
  • Ohio State University accepting new patients
    Columbus, Ohio, 43221, United States
  • Hospital of the University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Hospital for Special Surgery accepting new patients
    New York, New York, 10021, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Iowa
ID
NCT02075775
Study Type
Observational [Patient Registry]
Last Updated
April 1, 2017
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